ZENTEL Albendazole 200mg chewable tablet

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

albendazole, Quantity: 200 mg

Commercializzato da:

Aspen Pharmacare Australia Pty Ltd

Forma farmaceutica:

Tablet, chewable

Composizione:

Excipient Ingredients: lactose monohydrate; maize starch; microcrystalline cellulose; sodium starch glycollate; povidone; magnesium stearate; sodium lauryl sulfate; saccharin sodium; hypromellose; propylene glycol

Via di somministrazione:

Oral

Confezione:

6 tablets, 60 tablets, 2 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

For single dose or short term courses indicated in the treatment of single or mixed infestations of intestinal and tissue parasites, in adults and children over 2 years of age. Clinical studies have shown Zentel to be effective in the treatment of infections caused by: Enterobius vermicularis (pinworm/threadworm), Ascaris lumbricoides (roundworm), Ancylostoma duodenale and Necator americanus (hookworms), Trichuris trichiura (whipworm), Strongyloides stercoralis, animal hookworm lavae causing cutaneous lava migrans, and the liver flukes Opisthorchis viverrini and Clonorchis sinensis. Zentel is also indicated for the treatment of Hymenolepis nana and Taenia spp. (tapeworm) infections, when other susceptible helminths species are present. Treatment courses should be extended to 3 days. (see WARNINGS AND PRECAUTIONS)

Dettagli prodotto:

Visual Identification: A white to off-white, round, bevel edged, biconvex, film coated tablet, debossed Z on one face and plain on the other.; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

1994-12-01

Foglio illustrativo

ZENTEL TABLETS
1
ZENTEL TABLETS
_albendazole _
_CONSUMER MEDICINE INFORMATION _
_ _
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about ZENTEL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the possible risks of taking ZENTEL
against the expected benefits.
If you have any concerns about
taking this medicine talk to your
doctor or pharmacist.
Keep this leaflet with this medicine.
You may need to read it again.
WHAT ZENTEL IS
USED FOR
ZENTEL contains albendazole as the
active ingredient.
ZENTEL is used to clear worms or
parasites from the gut and other
tissues. ZENTEL is effective against
threadworm or pinworm,
roundworm, whipworm, tapeworm
and hookworm among others.
ZENTEL is thought to kill these
worms by causing them to starve.
The eggs, larvae and adult worms are
affected.
Your doctor may have prescribed
ZENTEL for another reason. Ask
your doctor if you have any questions
about why ZENTEL has been
prescribed for you.
There is no evidence that ZENTEL is
addictive.
BEFORE TAKING IT
_DO NOT TAKE ZENTEL IF: _
•
you have had an allergic reaction
to albendazole or any of the other
ingredients contained in this
medicine. Albendazole is also
contained in Eskazole. The
ingredients are listed at the end of
this leaflet. Signs of an allergic
reaction may include an itchy
skin rash, shortness of breath and
swelling of the face or tongue.
•
if you have taken albendazole
before and became unwell, tell
your doctor or pharmacist before
taking the first dose.
•
you are allergic to medicines
similar to albendazole such as
mebendazole (Sqworm, Vermox)
or thiabendazole (Mintezol).
•
YOU KNOW OR SUSPECT
YOU ARE PREGNANT.
Pregnancy must be avoided (ie
use effective contraceptive
measures) during treatment, and
for one month after stopping
ZENTEL.
In order to avoid taking ZENTEL
during early pregnancy, treatment
with ZENTEL should only be
started during the first w

Scheda tecnica

Zentel-PI
1
AUSTRALIAN PRODUCT INFORMATION
ZENTEL (ALBENDAZOLE)
CHEWABLE TABLETS
1
NAME OF THE MEDICINE
Albendazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZENTEL tablet contains albendazole 200 mg as the active
ingredient.
List of excipients with known effect include lactose monohydrate and
saccharin sodium. For the
full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ZENTEL 200mg chewable tablets are a white to off-white, circular,
biconvex, bevel edged film
coated tablet, debossed Z on one face and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Single dose or short term courses of ZENTEL are indicated in the
treatment of single or mixed
infestations of intestinal and tissue parasites, in adults and
children over 2 years of age.
Clinical studies have shown ZENTEL to be effective in the treatment of
infections caused by:
_Enterobius _
_vermicularis_
(pinworm/threadworm),
_Ascaris _
_lumbricoides_
(roundworm),
_Ancylostoma duodenale_ and _Necator americanus_ (hookworms),
_Trichuris trichiura_ (whipworm),
_Strongyloides stercoralis_, animal hookworm larvae causing cutaneous
_larva migrans,_ and the liver
flukes _Opisthorchis viverrini_ and _Clonorchis sinensis_.
ZENTEL is also indicated for the treatment of _ Hymenolepis nana_ and
_ Taenia_ spp. (tapeworm)
infections, when other susceptible helminths species are present.
Treatment courses should be
extended to 3 days (see 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
4.2
D
OSE AND METHOD OF ADMINISTRATION
ZENTEL 200mg chewable tablets may be crushed, chewed, or swallowed
whole.
Adults and Children (over two years):
•
_Enterobius vermicularis_, _ Ascaris lumbricoides_, _ Ancylostoma
duodenale,_ _ Necator americanus_
and _Trichuris trichiura_: 400mg (two ZENTEL 200mg tablets) as a
single dose, taken on an
empty stomach.
Zentel-PI
2
•
Suspected or confirmed _ Strongyloides stercoralis _ infestation:
ZENTEL 400mg once daily,
taken on an empty stomach for three consecutive days. Patients should
then be approp